FDA’s Medical Device Recall System is Deeply Flawed, Experts Say

The Food and Drug Administration’s system for recalling defective hip and knee replacements, surgical screws, and many other types of medical devices is seriously flawed, putting millions of patients at risk of life-threatening injuries, a leading medical industry watchdog foundation says.

Failure to adequately track which all medical devices have been implanted in which patients and other glitches in the FDA’s monitoring system make ordering recalls of the products ineffective and leaves defectively dangerous devices in patients with no real way of tracking them down, according to the Biomedical Research and Education Foundation.

“There is no system for being informed of what the problems are with the products you have in your body,” said Terry Fadem, president of the Philadelphia-based group, according to an Associated Press report posted on MSNBC.com. “Even your physician may not know.”

The automobile industry is required to maintain a centralized tracking system to follow vehicles for as long as they are on the road. That way, when recalls are required to remove potentially dangerous vehicles, the industry and federal regulators can quickly and efficiently notify vehicle owners.

Not so with millions of medical devices implanted in patients each year, Fadem’s group says.

Number of Implants, Recalls Increasing

The problems with tracking defective medical devices come at a time when both the numbers of the products implanted in patients and recalls issued are skyrocketing upward. Last year, the FDA said it recalled nearly 2,500 medical devices due to potential safety defects – about twice as many as the year before and a 164-percent increase from 2000.

Meanwhile, about one million Americans received either a new hip or knee replacement device in 2006 alone, a number that is expected to reach at least four million annually by 2030, the AP said, citing numbers from the American Academy of Orthopaedic Surgeons.

The FDA currently requires comprehensive tracking of only 14 types of devices, including pacemakers, mechanical heart valves and breast implants, according to the AP report. The agency says it is working to improve its tracking efforts to include better registration and including other types of devices.

Legislation May Improve System

We often read how the U.S. lags behind other nations in terms of quality of healthcare. Sadly, the FDA’s handling of tracking many medical devices is no different. Other nations around the world, including England, Australia, and Sweden, have systems in place that keep track on artificial joints. So the question is, why can’t the U.S. develop a similar system to protect its citizens?

The problem may be fixed as part of the sweeping overhaul of the nation’s healthcare system now moving through Congress, but that’s no guarantee. One thing we know for sure, until an effective fix is put in place to improve the tracking of millions of implanted medical devices, American patients remain unnecessarily at risk of developing potentially life-threatening health complications.

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